Kamada (KMDA)

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Kamada Provides Update on Recent Progress Achieved in Ongoing Pivotal Phase 3 Clinical Trial of Inhaled AAT

https://finance.yahoo.com/news/kamada-provides-recent-progress-achieved-120000851.html

Trial Recruitment Beginning to Accelerate; 30 Patients Enrolled and Treated to Date

Independent Data Safety Monitoring Board (DSMB) Recommends Study Continuation Without Modification for Fourth Time Since Study Initiation

Based on Encouraging Safety Observed to Date, Trial Inclusion Criteria Revised to Also Include Patients with Severe Airflow Limitation, Thereby Expanding Potential Patient Treatment Population

Company Intends to Meet with U.S. Food and Drug Administration and European Medicines Agency During First Half of 2023 to Discuss Study Progress and Potential Opportunities to Shorten the Regulatory Pathway

REHOVOT, Israel and HOBOKEN, N.J., Nov. 07, 2022 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a vertically integrated global biopharmaceutical company focused on specialty plasma-derived therapeutics, today provided an update on recent progress achieved in its ongoing pivotal Phase 3 InnovAATe clinical trial evaluating the safety and efficacy of the Company’s proprietary inhaled Alpha-1 Antitrypsin (AAT) therapy for the treatment of Alpha-1 Antitrypsin Deficiency (AATD).

Earlier this year, following the moderation of the COVID-19 pandemic, the study was expanded to additional sites across Europe and enrollment has recently begun to accelerate. To date, 30 patients have been enrolled for treatment, including 14 patients who have already completed the two-year study treatment period at the initial trial site in Leiden, the Netherlands. Importantly, none of these patients discontinued treatment prematurely and no drug-related serious adverse events were reported. Additionally, as part of routine and planned monitoring processes, and for the fourth time since study initiation, the independent Data Safety Monitoring Board (DSMB) recently recommended that the trial continue without modification. Moreover, based on the encouraging safety observed to date, the DSMB supported an expansion to the inclusion criteria to also include subjects with severe airflow limitation (40%<FEV1<80% of predicted; previously inclusion criteria were 50%<FEV1<80%), which is expected to further expedite patient enrolment.

“The strong association between AATD and Chronic Obstructive Pulmonary Disease (COPD) or emphysema suggests that inhaled administration of AAT directly to the lungs may benefit AATD patients,” said Jan Stolk, M.D., Department of Pulmonology, Member of European Reference Network LUNG, Leiden University Medical Center, The Netherlands. “Based on results published in the European Respiratory Journal in 2019, Kamada's previously completed randomized placebo-controlled clinical trial suggested that a decline in lung function as measured by FEV1, the most important parameter associated with shortness of breath, could be attenuated by daily AAT inhalation. Importantly, we have treated 19 patients to date at our site in Kamada's pivotal Phase 3 InnovAATe clinical trial, none of whom dropped out, indicating high patient adherence to the treatment. I am highly encouraged by the recent expansion of the trial to additional sites across Europe, and hope that the study results, once available, will validate that daily AAT inhalation is an effective and safe treatment for AATD patients suffering from emphysema. If so, I look forward to supporting regulatory approval of Kamada’s inhaled AAT for the benefit of the AATD community.”

“As the most advanced investigational product for AATD, a substantial commercial opportunity exists for Inhaled AAT to be a transformational next-generation augmentation therapy in the AAT market, which is already over $1 billion in annual sales in the U.S. and EU,” said Amir London, Kamada’s Chief Executive Officer. “We are pleased with the continued progress of the InnovAATe trial, the preliminary safety profile demonstrated to date, and support from AATD patients and physicians, which is reflected in the adherence to the treatment. We intend to meet with the FDA and EMA during the first half of 2023 to discuss trial progress and potential opportunities to shorten the regulatory pathway.”